|About||Kyowa Kirin commits to innovative drug discovery driven by state-of-the-art technologies. The company focuses on creating new values in the four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa Kirin brand, the employees from 40 group companies across North America, EMEA and Asia/Oceania unite to champion the interests of patients and their caregivers in discovering solutions to address unmet medical needs. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com.|
|How we share on the Vivli platform||Available studies are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data Request Form to request Kyowa Kirin’s data package(s).|
|Studies Listed for Sharing||Kyowa Kirin will list Phase 1, Phase 2, Phase 3 and Phase 4 Kyowa Kirin-sponsored interventional clinical studies that form part of the submission package for medicines and indications approved in North America (NA), Europe, and Japan (JP), after 15 January 2018.|
|Exceptions||Studies where there is reasonable likelihood that patients’ anonymity cannot be maintained. For example in very rare diseases, studies with very low patient numbers or studies performed at a single center.
When necessary to restrict information to protect commercially confidential information and intellectual property rights on rare occasions.
Data collected subject to legal, contractual or consent provisions that prevent further sharing of clinical data will be excluded.
Clinical studies where data labels and/or supporting documents are not in English.
Prematurely discontinued trials that have insufficient enrollment/exposure to warrant analysis may not be listed.
Data access or data provision may be restricted for the data that are technically difficult to provide or have practical limitations.
Interim data from completed or ongoing clinical trials will generally not be shared.
Information provision may be limited for studies that are ongoing or planned for regulatory review by competent regulatory authorities.
|When Studies are Listed||Studies are listed after the medicine and indication have received NA, Europe, and JP marketing approval, and after the development program has been fully completed worldwide, on or after the 15 January 2018 and after the results from the studies have been accepted for publication.|
|Additional Conditions for Data Access||Access may be declined on rare occasions, for example, where there is a potential conflict of interest or an actual or potential competitive risk.|
|What information will be provided||Where available, the following anonymised patient level data and information is provided for each clinical study:
Dataset provided: CDISC/SDTM、ADaM
Definition provided: define.xlm
Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical trial and information about all amendments.
Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.
Reporting and analysis plan. This describes methods of analysis and procedures for data handling that Kyowa Kirin used for the study report.
Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.
Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices that contain no patient relevant data (e.g. audit certificates or manuals from providers of various diagnostic services) as well as individual patient level data (e.g. narratives) are not included. Documents will be redacted to protect personal data of study participants, study personnel, and Kyowa Kirin employees, and to protect Kyowa Kirin’s commercially confidential information, including intellectual property rights.
|Questions or enquiries||Researchers can enquire about the availability of data from Kyowa Kirin clinical studies that are not listed on Vivli before they submit a research proposal.|
|Review Criteria for Data Requests||The primary manuscript of the study has been published or accepted for publication.
Whether Kyowa Kirin is able to provide the requested data. For example, some non-interventional (or observational) studies use data from third party databases under license agreements which prevent Kyowa Kirin from providing access to the data. Researchers may seek access to data directly from these third party databases under similar agreements.
Whether Kyowa Kirin has the legal authority to provide the data. For example, Kyowa Kirin may not have the legal authority because the medicine has been out-licensed to another company.
If agreement to disclosure of clinical data is not gained with a co-development/research/marketing/promotion partner for a compound/product.
Whether Kyowa Kirin considers it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
If there are considerable operational constraints (costs, resource) to providing access to the data.
|Data Request Review Process||Access to data is determined by the Independent Review Panel based on the scientific merit of the research proposal. In exceptional circumstances, access to data may be declined by Kyowa Kirin, for example, where there is a potential conflict of interest or an actual or potential competitive risk.|
|Access to study documents without participant-level data||In addition, researchers can enquire about access to clinical study documents only (without patient level data, such as the Clinical Study Report) by completing the online enquiry form.|
|Clinical Study Register or Website||https://www.kyowakirin.com/|